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Randomized Study of Erlotinib vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Primary Objective: To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over observation for patients with completely resected stage IB (greater than or equal to 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy. Secondary Objectives: To assess whether adjuvant therapy with erlotinib will result in improved disease free survival (DFS) over observation for patients with completely resected stage IB (greater than or equal to 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To evaluate the safety profile of erlotinib in the adjuvant setting. To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 and 10 years over observation for patients with completely resected stage IB (greater than or equal to 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status. To study detection of circulating EGFR mutation in cell-free plasma DNA as a prognostic marker in resected early stage NSCLC.

Primary Objective: To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over observation for patients with completely resected stage IB (greater than or equal to 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy. Secondary Objectives: To assess whether adjuvant therapy with erlotinib will result in improved disease free survival (DFS) over observation for patients with completely resected stage IB (greater than or equal to 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To evaluate the safety profile of erlotinib in the adjuvant setting. To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 and 10 years over observation for patients with completely resected stage IB (greater than or equal to 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status. To study detection of circulating EGFR mutation in cell-free plasma DNA as a prognostic marker in resected early stage NSCLC.